A Study to Assess Effectiveness and Tolerability of Zavegepant as an Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Zavegepant (Zavzpret) is approved for the acute treatment of migraine with or without aura in the US. The purpose of this study is to investigate the effectiveness and tolerability of zavegepant for the acute treatment of migraine attacks amongst participants who are using calcitonin gene-related peptide (CGRP) migraine preventive treatments.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Meets International Classification of Headache Disorders 3 (ICHD-3) diagnostic criteria for migraine with or without aura

• At least 18 years of age

• 2- 8 migraine attacks per month

• Participants should be on a calcitonin gene-related peptide (CGRP)-targeting preventive migraine medication on a stable dose for a) ≥2 months prior to zavegepant treatment if an oral gepant or a monoclonal antibody (mAb) injected monthly, or b) at least two treatments if a mAb injected each 3 months.

‣ Atogepant

⁃ Eptinezumab

⁃ Erenumab

⁃ Fremanezumab

⁃ Galcanezumab

⁃ Rimegepant

∙ • Must have 4 or more migraine days per month, on average, during the 2 months prior to the Screening Visit, according to participant self-report.

Locations
United States
Arizona
Mayo Clinic in Arizona
RECRUITING
Phoenix
Time Frame
Start Date: 2024-03-22
Estimated Completion Date: 2027-03
Participants
Target number of participants: 200
Treatments
Experimental: Zavegepant Treatment
Participants will receive zavegepant to treat up to 8 migraine attacks over 24 weeks.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov